D-0364-2024 Class III Ongoing

Recalled by Contract Pharmaceuticals Limited Canada — Mississauga

Recall Details

Product Type
Drugs
Report Date
March 13, 2024
Initiation Date
February 20, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45,875 bottles

Product Description

Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61

Reason for Recall

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Distribution Pattern

Nationwide in the U.S. and Puerto Rico

Code Information

Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025